Earlier this month, I wrote that the ACLU filed suit on behalf of patients and researchers against Myriad for its patents related to breast cancer. This suit is particularly interesting as a direct challenge to whether human genes should be the subject of a patent–to many a question that is long overdue. This question was glossed over after the 1980 case of Diamond v. Chakrabarty, in which the Supreme Court held that a genetically modified bacterium is patentable subject matter. The likely suspects to challenge such patents, other biotech companies that depended on patents to secure investment, had an interest in not having all patents of this type declared invalid. Why did the ACLU wait such a long time to bring this suit? It’s likely that recent decisions addressing the scope of patentable subject matter signaled that the time was ripe to address the issue, perhaps in a way that would result in a narrower interpretation of subject matter eligibility (Bilski, Comiskey, Classen).

The suit raises several questions, though I focus on the following four issues:

1. Are human genes within the scope of patentable subject matter? This is the question that follows naturally from the Bilski decision that patent claims must be narrowly tailored to cover a particular application of a fundamental principle, such as a law of nature, rather than preempting the principle itself. A claim would need to be tied to a machine or be transformative to be patent-eligible. The method claims at issue are not tied to a particular machine. One could argue that identifying a gene that corresponds with an increased susceptibility to disease is transformative-it takes biological material and transforms it into information about disease risk. For the composition of matter claims, isolating DNA would physically transform it, though it’s unclear whether such a transformation would be seen as insignificant extra-solution activity.

2. Does imposing high costs for patented tests that implicate human health violate the First Amendment or fail to promote progress? I think this is a hard argument to make, given that this is the essence of the patent bargain. If you invest and discover something, you can charge what you want for 20 years from your filing date. We don’t invalidate patents on MRI systems or life-extending pharmaceuticals based on the costs their patent holders decide to charge, though the courts have imposed a reasonable royalty in response to unauthorized use (eBay v. MercExchange) or (rarely) compulsory licensing has been required.

3. Does allowing a patent that (potentially) excludes others from correlating information violate the First Amendment? It’s hard to imagine standing would be satisfied here. I doubt that any patent holder, even Myriad, would bring suit against a doctor for performing a correlation, whether performed mentally or even after disclosing the results to a patient.

4. Does allowing a patent that prevents a second opinion of a medically relevant test conflict with the First Amendment or fail to promote progress? The First Amendment argument seems a bit of a stretch, though perhaps preventing a patient from obtaining a second opinion does undermine the purposes of the patent system. More particularly, it prevents the public from verifying what the patent holder claims to own, which seems to be part of the disclosure requirement of the patent system.

I think these types of patents are becoming less important, in part because of the narrowed scope of patentable subject matter eligibility, the broadened ability to show obviousness, and the likelihood of finding invalidating prior art from the Human Genome Project. The decreased pace of discovery of single genes that correlate with disease also lessens the significance of this suit. It’s challenging to get decent empirical evidence on under what circumstances these types of patents ultimately encourage or hinder innovation, but in light of the importance of these discoveries to health, the more prudent approach is to assume that they encourage it.

3 Responses to “More on the ACLU Suit to Invalidate Myriad’s Patents on Breast Cancer Genes”

As I understand it, patents on disease-related genes typically include several claims – including claims for the composition of matter that is the cDNA, for the use of the information for testing purposes, and for the use of that information for treatment (through gene therapy or otherwise). The composition of matter claims have created the most political unhappiness, but will mostly be gone in a few years. A patent to use that information for testing or treatment has been somewhat less objectionable. Am I right in understanding the new Federal Circuit decisions (and perhaps S Ct tea leaves) as undermining the second type (the use patent) more than the composition of matter patents?

Thanks for the comments. I think both types of patents are being called into question. With regard to the use patents, the Supreme Court recently decided to grant cert. in In re Bilski. Bilski’s patent covers a business method of hedging risk. The Federal Circuit attempted to avoid Supreme Court review, some commentators believe, by adopting the machine or transformation test to determine whether patent claims preempt a fundamental principle (e.g. an abstract idea, algorithm or law of nature). How the Supreme Court will determine subject matter eligibility for patents in Bilski is anyone’s guess. The dissenting opinion in the Lab Corp. v. Metabolite case further suggests that patents on correlations are disfavored by at least some of the Justices.

The Federal Circuit’s decision in Ariad v. Lilly, in which Ariad has filed a petition for rehearing, also affects the viability of these types of patent claims. The court examined the level of detail required to satisfy the written description requirement. In invalidating claims to methods for suppressing the level of activity for a transcription factor, the court held that the specification failed to provide an adequate description of the molecules that are capable of reducing the activity. The discussion in the specification of three classes of molecules, a method of reducing activity from molecules in one class, and a few examples of molecules from one class was not sufficient to support broad claims to methods for reducing activity. One has to wonder, in light of Ariad, to what extent Myriad’s claims to methods of screening for the BRCA genes are adequately described in its patents. This may also touch on the patents for the compositions of matter as well. Should Myriad’s composition of matter patents be upheld to cover all methods that can be associated with a particular gene, particularly when the patent holder was only in possession of a small number of methods at the time of invention?

In addition, the the Federal Circuit’s decision in In re Kubin will decrease the likelihood that these types of composition of matter claims will be granted. In Kubin, the court determined that claims to cDNA encoding a known protein were obvious where there was some motivation to clone the cDNA and a reasonable expectation of success in view of enabling instructions in the prior art. While Myriad’s composition of matter claims would probably not be obvious in light of Kubin, given the level of skill in the art at the time of invention, more recent composition of matter claims could be called into question.